Z-0408-2018Class II

smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx...

Name: Z-0408-2018 smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx...
Creator: Smith & Nephew, Inc.
Published: 2017-11-29
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2017-11-29 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates... on 2017-11-29. FDA classified it as Class II and gives the reason as "One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0408-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-29
Posted: 2018-01-24
Terminated: 2020-09-01
Recalling firm: Smith & Nephew, Inc.
Product: smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
Product code: HRS Plate, Fixation, Bone
Reason for recall: One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Smith & Nephew Inc. initiated its recall by email on November 29, 2017. The consignee was directed to return the recalled product. For further questions, please call (901) 396-2121.
Quantity in commerce: 12
Distribution: US Distribution to the state of OR, and Internationally to Colombia.
Product codes and lots: 17AM14602

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0408-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0408-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-24

Product code HRS

K140814Class IIEvos Mini-Fragment Plating SystemSmith & Nephew, Inc. / cleared 2014-05-07

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)